CelAgace™ OraRinse Solution for Treatment of Candidiasis

CelAgace™ OraRinse (CAOR) Pilot Clinical Study for Management of Candidiasis Associated With Grade 0-II Mucositis

CelAgace™ OraRinse (silver citrate complex and acemannan) Solution is planned to be evaluated for safety and effectiveness as a potential treatment for candidiasis, a yeast infection, commonly known as thrush, which is associated with mouth sores.

Study Overview

• Status: Not yet recruiting
• Conditions: Candidiasis, Oral
• Intervention / Treatment: Drug: silver citrate complex and acemannan

Detailed Description

CelAgace™ contains two active ingredients, a silver citrate complex salt (0.01mg/ml) that has demonstrated laboratory effectiveness against yeast organisms and acemannan (4.0mg/ml), a purified extract isolated from the inner leaf gel of the Aloe vera plant that has been used as a key ingredient in other oral care products. Patients will swish and spit the product 4 times daily (after meals and at bedtime) for 14 days. Following an initial office visit, patients will be evaluated on days 7 and 14 to determine response to the product.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jacqueline M. Plemons, DDS, MS; Phone Number: 214-828-8467; Email: jplemons@tamhsc.edu
• Study Contact Backup: Name: Celeste M. Abraham, DDS, MS; Phone Number: 214-828-8467; Email: cabraham@tamhsc.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas A&M University College of Dentistry
      • Contact: Jacqueline M. Plemons, DDS, MS; Phone Number: 214-828-8467; Email: jplemons@tamhsc.edu
      • Contact: Celeste M. Abraham, DDS, MS; Phone Number: 214-828-8467; Email: cabraham@tamhsc.edu
      • Sub-Investigator: Celeste M. Abraham, DDS, MS
      • Principal Investigator: Jacqueline M. Plemons, DDS, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Radiation induced oral mucositis with resulting candidiasis
• Chemotherapy induced oral mucositis with resulting candidiasis
• Oral mucositis due to being immunocompromised with resulting candidiasis
• Stomatitis due to other causes with resulting candidiasis
• Currently have mild to moderate mucositis

Exclusion Criteria:

Patient:

• under the age of 18
• pregnant or breastfeeding
• inability to use an oral rinse
• hypersensitivity to Aloe Vera and/or Silver
• whose candida rinse culture was performed greater than 10 days prior to study entry.
• has any sort of removable dental appliance
• with previous or current history of any cancer of the oral cavity
• who received therapy for candidiasis within the past 30 days
• who used antifungal medication in the last 30 days
• who has severe to life threatening oral muositis (Grade III-IV) oral mucositis
• with impaired renal or hepatic function
• receiving high dose chemotherapy and total body irradiation in preparation for Hemopoietic Stem Cell Transplant (HSCT) or Concomitant use of Kepivance® (palifermin or rhKGF)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: silver citrate complex and acemannan; This is a single arm open pilot trial. All participants will receive study drug.	Drug: silver citrate complex and acemannan; Oral rinse solution with each dose containing 100μg silver citrate complex and 40mg acemannan; Other Names: CelAgace™ OraRinse Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical cure as demonstrated by change and reduction from baseline in typical candida lesions and a negative candida rinse culture	Rinse culture will be taken on Days 1, 7 and 14 to quantify Candidal Colony Forming Units and observational assessment will be done at study entry, Day 1, Days 3, 7, 14 using the WHO grading scale for response evaluation.	Days 1(Baseline), 3, 7 and 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Pain	Patients will complete a pain quality assessment rating scale (PQAS) during the course of the study.	Days 1, 3, 7, 14

Collaborators and Investigators

• Sponsor: CelaCare Technologies, Inc.
• Collaborators: Texas A&M University
• Investigators: Principal Investigator: Jacqueline M. Plemons, DDS, MS, Texas A&M University College of Dentistry

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (Actual): August 16, 2017

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Oral Candidiasis, Thrush, Oral Moniliasis
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Mouth Diseases; Bacterial Infections and Mycoses; Mycoses; Candidiasis; Candidiasis, Oral; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Gastrointestinal Agents; Adjuvants, Immunologic; Acemannan
• Other Study ID Numbers: IRB2017-0042

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No